Actively Recruiting
A Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies
Led by Central Hospital, Nancy, France · Updated on 2025-05-06
95
Participants Needed
1
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). It is characterized by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon. Although biologic therapies have provided clinical benefits to patients, these goals are still poorly met, due to the limited knowledge of the underlying mechanisms of immunopathology and the lack of predictive biomarkers that would allow proper patient stratification. The hypothesis of this study is that by identifying new biomarkers in blood, stool and tissue that (i) predict response (or non-response) to therapy prior to the start of treatment and (ii) predict response to therapy in the early phase of treatment will allow to find the right treatment for the right patient (personalized medicine).
CONDITIONS
Official Title
A Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 18 years of age or older at the time of signing consent
- Established diagnosis of ulcerative colitis for at least 3 months
- Moderate to severe active ulcerative colitis defined by a Mayo Score of 6 or higher
- Moderate to severe active ulcerative colitis defined by an endoscopy score of 2 or higher
- Indication to start biological or small molecule therapies including anti-TNF, anti-IL12/23, anti-integrin, or JAK inhibitors
- Stable corticosteroid dose of 20 mg prednisone or less for at least 3 weeks before baseline if on corticosteroids
- Indication for endoscopy to assess disease activity according to standard care and guidelines
- Ability to comply with study procedures
- Affiliation with or beneficiary of a social security plan
- Informed about the study and able to sign informed consent
You will not qualify if you...
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or radiation colitis
- Absolute contraindications to endoscopy or complications from previous endoscopy
- Bleeding disorders
- Indication for surgery for ulcerative colitis
- Use of rectal topical therapy (enemas or suppositories) within 2 weeks before baseline
- Treatment with more than 20 mg prednisone within 3 weeks before baseline
- Anemia with hemoglobin less than 10 g/dl at baseline
- Any condition assessed by the investigator as unsuitable for study participation
- Pregnant, parturient, or breastfeeding women
- Minors who are not emancipated
- Adults under legal protection or incapable of giving consent not under legal protection
- Persons deprived of liberty by judicial or administrative decision or under psychiatric care as defined by law
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Central Hospital
Nancy, Lorraine, France, 54500
Actively Recruiting
Research Team
L
Laurent MD Peyrin-Biroulet, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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